Study of BB-031 for Acute Ischemic Stroke

This study, called RAISE, is testing a new drug called BB-031 for people who have had an acute ischemic stroke. An ischemic stroke happens when a blood clot blocks blood flow to the brain. The study aims to see how safe BB-031 is and how well people tolerate it. You might be able to join if you are 18 or older, have had an acute ischemic stroke affecting the front part of your brain, and your symptoms started within 24 hours. You would receive either BB-031 or a placebo (an inactive substance like salt water). The main goal is to check for serious bleeding in the brain within 24 hours of treatment. The study plans to enroll 228 patients, but its current recruitment status is unclear.

Study design
This is a randomized, placebo-controlled, double-blinded study with two parts, aiming to enroll 228 participants. Participants will receive either BB-031 or a placebo.
What's involved
You would be screened after a stroke diagnosis and then receive a single dose of the study drug or placebo. You would be followed for 90 days after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 90 days after receiving treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06226805

Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

Recruiting
PHASE2Ages 18+InterventionalPrevention
Basking Biosciences, Inc.
~228 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:BB-031Placebo

At a glance

Recruiting sites
21 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Symptomatic Intracranial Hemorrhage (sICH)
Measured over 24 hours
Acute Ischemic Stroke

NCT06226805

Where you'd take part

This study runs at 25 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cooper University Hospital

    Camden, New Jerseyno site contact published

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, Australiano site contact published

    Recruiting

  • Henry Ford Hospital

    Detroit, Michiganno site contact published

    Recruiting

  • HonorHealth Bob Bove Neuroscience Institute

    Scottsdale, Arizonano site contact published

    Recruiting

  • John Hunter Hospital

    New Lambton Heights, New South Wales, Australiano site contact published

    Recruiting

  • Memorial Hermann Hospital

    Houston, Texasno site contact published

    Recruiting

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohiono site contact published

    Recruiting

  • Monash Medical Centre

    Clayton, Victoria, Australiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Michael D Hill, MD · PRINCIPAL_INVESTIGATOR · University of Calgary
  • Shahid M Nimjee, MD, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University

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Eligibility criteria

Inclusion

Clinical diagnosis of acute ischemic stroke
18 years or older
Anterior circulation intra-cranial occlusion
NIHSS score \>3
Onset of stroke symptoms within 24 hours of enrollment

Exclusion

Large volume ischemic stroke
Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage
Chronic intracranial occlusion
Weight \>125kg
Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors
Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding
Prior stroke within 90 days
Unable to undergo a contrast brain perfusion scan with either MRI or CT
  • Symptomatic Intracranial Hemorrhage (sICH)24 hours

    Proportion of participants having a sICH